Suresteppro/Surestepflexx Professional Blood Glucose Management System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K023194 FDA 510(k)
- FDA Product Code
- CGA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1345 FDA 510(k)
- Regulation Number
- 862.1345 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Professional Blood Glucose Management System, designed for clinical use to measure blood glucose levels. It employs glucose oxidase chemistry to provide accurate readings, supporting diabetes management in healthcare settings. The system is classified as a Class II medical device under FDA regulations, with a focus on clinical chemistry applications.
The SureStep Pro/SureStep Flexx system is intended for single-use in professional environments such as hospitals or clinics. It includes reusable components like the bedside unit and disposable test strips for blood glucose measurement. The device is not MRI-safe and requires proper storage to maintain sterility and functionality. Authorized under FDA 510(k) clearance (K023194), it adheres to regulatory standards for glucose monitoring systems.
Frequently asked questions
What is the primary use of the SureStep Pro/SureStep Flexx Professional Blood Glucose Management System in clinical settings?
The SureStep Pro/SureStep Flexx system is designed for professional use in healthcare environments like hospitals or clinics to measure blood glucose levels accurately. It employs glucose oxidase chemistry to support diabetes management by providing reliable readings in clinical settings.
Is the SureStep Pro/SureStep Flexx system intended for single-use or reusable components, and what does this mean for my workflow?
The system is intended for single-use with disposable test strips, while components like the bedside unit are reusable. This means you’ll need to replace strips after each use, but the core device can remain in service, reducing overall waste and maintenance.
How should I store the SureStep Pro/SureStep Flexx system to ensure it remains functional and sterile?
Proper storage is critical to maintain sterility and functionality. Since the system is not MRI-safe, it should be stored away from magnetic fields. The manufacturer recommends following the included instructions for humidity, temperature, and light exposure to preserve performance and sterility.
What regulatory pathway does the SureStep Pro/SureStep Flexx system follow, and what does this mean for compliance?
The device is authorized under FDA 510(k) clearance (K023194) and classified as a Class II medical device under FDA regulations. This means it has undergone a premarket submission process to demonstrate substantial equivalence to a predicate device, ensuring it meets regulatory standards for glucose monitoring systems in clinical chemistry.
Are there different models or sizes available for the SureStep Pro/SureStep Flexx system, and how do I determine which one fits my needs?
The system includes multiple test strip variants (as indicated by the FEI numbers), but the core device itself is a single professional unit designed for bedside use. The choice of test strips may vary based on specific clinical needs or patient populations, but the bedside unit remains consistent across models. Check the packaging or consult the manufacturer for compatibility with your workflow.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: LIFESCAN SURESTEPFLEXX OPERATOR'S MANUAL Pdf Download, LIFESCAN SURESTEP PRO OPERATOR'S MANUAL Pdf Download, Lifescan SureStep blood glucose monitoring system User Manual, Lifescan SureStep Pro User Manual | 117 pages - ManualsDir.com, Suresteppro/Surestepflexx Professional Blood Glucose Management System ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K023194 | Class II | Active |
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Manufacturer
- Manufacturer
- Lifescan, Inc.
Sources (1)
- FDA 510(k) K023194 24 fields · synced Sep 19, 2026